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Medicago Reports Positive Phase I Results for its Avian Flu Pandemic Vaccine

Quebec City (ots/PRNewswire)

Medicago Inc.  a
biotechnology company focused on developing  highly effective and
affordable vaccines based on proprietary manufacturing  technologies
and Virus-Like Particles (VLPs), today reported positive interim
results from a Phase I human clinical trial with its H5N1 Avian
Influenza  vaccine candidate ("H5N1 vaccine"). The vaccine was found
to be safe, well  tolerated and also induced a solid immune response.
"We are very pleased with the results from this study. This trial
was the  first ever clinical evaluation of a plant-based Influenza
VLP vaccine and  shows that Medicago's vaccine is safe in humans,"
said Andy Sheldon,  President and CEO of Medicago. "We believe our
novel vaccine candidate,  coupled with our rapid response and low
cost manufacturing system offers a  preferred option to increase the
speed of a public health response in the  event of a pandemic
outbreak. Looking ahead, the successful completion of  this trial
should enable us to formalize various partner agreements. It may
also allow us to access new sources of non-dilutive funding available
through  U.S. grant programs and by organizations interested in
funding the  development of better technologies for pandemic vaccine
production."
The Phase I study was designed to investigate the safety of the
Company's  H5N1 alum-adjuvanted pandemic vaccine candidate and to
provide an initial  indication of the immune response. A total of 48
healthy volunteers between  the ages 18 to 60 received two doses of
either Medicago's vaccine at doses of  5, 10 or 20 micrograms (mcg)
or a placebo. No serious adverse events were  reported during the
trial and the vaccine was found to be well tolerated at  all three
dose levels. Local site reactions were mild and the incidence of
systemic side effects was comparable between the H5N1 vaccine groups
and the  placebo. As planned in the initial design, adverse event
monitoring will  continue for six months after administration of the
second vaccine dose. The  trial was conducted at the Vaccine
Evaluation Center of McGill University in  Montreal, Canada, under
the supervision of Dr. Brian Ward.
Preliminary results showed that 81% of immunized subjects
developed an  immune response against the H5N1 virus after the second
immunization. A four- fold increase in HI titers from baseline in 58%
of subjects was observed in  the 20 mcg group. HI titers greater than
1:40 were developed in 50% of the  subjects in the 20 mcg group. The
H5N1 vaccine also induced the production of  antibodies
cross-reacting with two other strains of H5N1 Avian Influenza
suggesting Medicago's vaccine potential for cross-protection.
"Results at these lower dosage levels have not been reported for
an H5N1  vaccine manufactured with a novel vaccine manufacturing
technology," said  Nathalie Landry, VP Product Development of
Medicago. "H5N1 vaccines are  poorly immunogenic in humans and are
known to require repeated  administrations with an adjuvant to elicit
an immune response at low doses."
Full results of this trial will be submitted for publication in a
scientific journal and will be available in the coming months. Based
on these  results, Medicago will proceed with a Phase II clinical
trial, expected to  commence during the first half of 2010.
About Medicago's pandemic flu vaccine candidate
Medicago's H5N1 vaccine candidate was formulated to protect
against the  Indonesian influenza virus. It is manufactured in
Nicotiana benthamiana, a  relative of the tobacco plant, using the
Company's proprietary VLP  technology. VLPs may have several
advantages over traditional flu vaccines.  They are made to look like
a virus, allowing them to be recognized readily by  the body's immune
system, however, they lack the core genetic material making  them
non-infectious and unable to replicate. FDA-approved H5N1 influenza
vaccines in the United States require two 90-microgram doses,
administered at  least four weeks apart to achieve appropriate level
of antibodies in 44% of  vaccinated individuals. Because Medicago's
technology requires the genetic  sequence of a viral strain and not
the live influenza virus, vaccines can be  manufactured within four
weeks of obtaining the genetic sequence of a  pandemic strain. This
is in contrast with current manufacturing technologies  which rely on
strain adaptation and can only deliver a vaccine six to nine  months
after a pandemic is declared.
About Medicago
Medicago is committed to provide highly effective and affordable
vaccines  based on proprietary Virus-Like Particle (VLP) and
manufacturing  technologies. Medicago is developing VLP vaccines to
protect against H5N1  pandemic influenza, using a transient
expression system which produces  recombinant vaccine antigens in
non-transgenic plants. This technology has  potential to offer
advantages of speed and cost over competitive  technologies. It could
deliver a vaccine for testing in about a month after  the
identification and reception of genetic sequences from a pandemic
strain.  This production time frame has the potential to allow
vaccination of the  population before the first wave of a pandemic
strikes and to supply large  volumes of vaccine antigens to the world
market. Additional information about  Medicago is available at
http://www.medicago.com.
Forward Looking Statements
This news release includes certain forward-looking statements
that are  based upon current expectations, which involve risks and
uncertainties  associated with Medicago's business and the
environment in which the Company  operates. Any statements contained
herein that are not statements of  historical facts may be deemed to
be forward-looking, including those  identified by the expressions
"anticipate", "believe", "plan", "estimate",  "expect", "intend", and
similar expressions to the extent they relate to  Medicago or its
management. The forward-looking statements are not historical  facts,
but reflect Medicago's current expectations regarding future results
or events. These forward-looking statements are subject to a number
of risks  and uncertainties that could cause actual results or events
to differ  materially from current expectations, including the
matters discussed under  "Risks Factors and Uncertainties" in
Medicago's Annual Information Form filed  on March 25, 2009 with the
regulatory authorities. Medicago assumes no  obligation to update the
forward-looking statements, or to update the reasons  why actual
results could differ from those reflected in the forward-looking
statements.
Neither TSX Venture Exchange nor its Regulation Services Provider
(as  that term is defined in the policies of the TSX Venture
Exchange) accepts  responsibility for the adequacy or accuracy of
this release.
For further information: Medicago, Inc., Andy Sheldon, President
and CEO,  +1-418-658-9393 x135; Medicago Inc., Pierre Labbe, Chief
Financial Officer,  +1-418-658-9393 x135

Contact:

CONTACT: For further information: Medicago, Inc., Andy Sheldon,
Presidentand CEO, +1-418-658-9393 x135; Medicago Inc., Pierre Labbe,
Chief FinancialOfficer, +1-418-658-9393 x135